Data / Medical devices / Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) / United States
FDA-registered makers of Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) (product code HIN). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- Product code
- HIN
- Country
- United States
Makers of Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 2 | November 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 1 | June 29, 2012 | 0 | 0 | 0 | api.fda.gov |
| Elmed, Inc. | Glendale Heights, IL, United States | Manufacturer | 1 | November 15, 1994 | 0 | 0 | 0 | api.fda.gov |
| Grace Manufacturing Inc | Russellville, AR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.